Application for a Licence for Controlled Drugs (other
than to Import or Export)
MISUSE OF DRUGS ACT 1977
MISUSE OF DRUGS REGULATIONS 2017
Notes:
Licences are required to manufacture controlled drugs described in Schedules 1 to 5 of the Misuse
of Drugs Regulations 2017 (the Regulations). Licences are also required to supply, offer to supply
and/or to possess controlled drugs described in Schedules 1 and 2 of the Regulations.
A registration is required for the possession, supply and offer to supply controlled drugs described
in Schedules 3, 4 and 5 of the Regulations; separate application forms for registrations are also
available.
The adequacy of the arrangements for the safe custody of controlled drugs described in Schedules
1, 2, and 3 of the Regulations, held under licence or registration, may from time to time be the
subject of inspection by An Garda Síochána. This inspection report or certificate will be taken into
account in the granting of licences and a copy must be submitted with every application.
Certificates issued by An Garda Síochána relating to safe custody provisions of controlled drugs
remain in force for a period of two years.
Every application for a licence must be accompanied by all the associated supporting documents
as detailed in section 7 of the application. Please complete all sections of the application form or
mark ‘Not applicable’ as appropriate. Incomplete application forms or those missing supporting
documents may not be processed and may result in delays to the application process and return
or cancellation of the application. Please contact [email protected] with any queries
regarding the submission.
SECTION 1
APPLICANT DETAILS
Name of applicant
Address of applicant
Eircode
Legally registered company name and
address with the Companies Registration
Office
(Please ensure the name and address
matches the details held by the CRO.)
CRO number
Name of premises to be licensed
Address of premises to be licensed
Eircode
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Name of manager or person in charge
E-mail address
Contact number
SECTION 2
PURPOSE AND TYPE OF LICENCE REQUIRED
Sufficient information should be supplied to justify the granting of the licence.
Please indicate the operation type by checking the relevant box below:
Manufacturer (Licence type e.g. possession, production, supply
Wholesaler (Licence type e.g. possession, supply
University or laboratory (Licence type e.g. possession
)
)
)
Private hospital, clinic or tissue establishment (Licence type e.g. possession, for use at
licenced location
)
Advanced paramedic / paramedic (Licence type e.g. possession, limited authority to supply
)
For all licences please give a brief statement identifying the purpose for which the controlled
drugs will be used:
(e.g. retain samples, forensic/chemical analysis, research and development of ……, wholesale
distribution)
For private hospitals, clinics, tissue establishments please provide the following information:
(Only provide roles and job titles, not names of personnel)
(a) Role of responsible person (i.e. medical practitioner or pharmacist)
(b) Job title of responsible person (e.g. Clinical Director/Chief Pharmacist)
(c) Job title of principal prescriber (e.g. Clinical Director, Chief Medical Officer or equivalent)
Note: the role of the responsible person is to ensure conditions of the licence are complied
with; the principal prescriber has overall responsibility for prescribing practices in facility.
For renewal licences please advise if you are adding/removing any drugs on the licence.
If removing drugs from the licence please confirm that these are no longer held on the
premises.
For activities in respect of controlled drugs described in Schedules 1 to 5 of the Regulations,
please indicate by marking in the tables below the drugs and activity type for which licences
are required.
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Note: separate licences are required for production, for supply and for possession under specific
circumstances; therefore please indicate all activities for which a licence is required.
For all possession licences (except private hospitals, clinics or tissue establishments) please
indicate in the tables below the approximate quantity of each controlled drug to be held at
the licenced premises on an annual basis.
Note: For advanced paramedics/paramedics please state both the maximum quantity to be in
their possession and the maximum quantity to be held at the premises.
PART A : SCHEDULE 1 AND 2 DRUGS
Drugs
To produce
base drug
(including
salts)
To produce
preparations
To
supply
To
possess
Quantity Held
(grams/mls)
(possession
licences only)
Schedule 1*
Please specify
below:
Schedule 2
Alfentanil
Buprenorphine
Cocaine
Codeine
Dihydrocodeine
Dipipanone
Etorphine
Fentanyl
Hydrocodone
Hydromorphone
Levorphanol
Medicinal Opium
(this includes
papveretum)
Methadone
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PART A : SCHEDULE 1 AND 2 DRUGS
Drugs
To produce
base drug
(including
salts)
To produce
preparations
To
supply
To
possess
Quantity Held
(grams/mls)
(possession
licences only)
Methylphenidate
Morphine
Nalbuphine
Oxycodone
Pethidine
Pholcodine
Remifentanil
Quinalbarbitone
Tapentadol
Others (Please
specify)
* Please note that licences may be granted in respect of these drugs in limited circumstances which
include use in research, forensic science applications and as an essential starting material or
intermediate in an industrial manufacturing process in accordance with the Misuse of Drugs
(Designation) Order 1998, as amended..
SCHEDULE 3, 4 AND 5 DRUGS Licence to produce only
PART B : SCHEDULE 3 DRUGS
Licence to produce
(For possession and/or supply only of Schedule 3, 4 and 5 drugs, a separate registration is
required. Please see registration application form on www.hpra.ie)
Base drugs (including salts)
Preparations
Amylobarbitone
Flunitrazepam
Ketamine
Methylphenobarbitone
Pentazocine
Pentobarbitone
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Phenobarbitone
Phentermine
Temazepam
Others (Please specify)
PART C : SCHEDULE 4 DRUGS
Licence to produce
(For possession and/or supply only of Schedule 3, 4 and 5 drugs, a separate registration is
required. Please see registration application form on www.hpra.ie)
Base drugs (including salts)
Preparations
Alprazolam
Bromazepam
Chlordiazepoxide
Clobazam
Clonazepam
Diazepam
Flurazepam
Lorazepam
Lormetazepam
Midazolam
Nitrazepam
Prazepam
Selegiline
Triazolam
Zolpidem
Zopiclone
Others (Please specify)
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SECTION 3
OPERATION TYPE AND PREPARATIONS PRODUCED
In the space provided below or via a separate referenced attachment, give a brief description of
the operation(s) for which the licence(s) are required and, if applicable, provide a list and details
of all the preparations to be produced under the authority of the licences for which application
is made (i.e. preparations in Schedule 2, 3, 4 or 5).
SECTION 4
SAFE CUSTODY ARRANGEMENTS
Give a brief description in the space provided below or in a separate referenced attachment.
Applicants are reminded of their responsibility to ensure that all controlled drugs held under
licence or registration are kept in a manner so as to prevent unauthorised access to the drugs.
Please include details of the safe (if applicable) and who will have access to it. A declaration
from An Garda Síochána must also be submitted in addition to this information.
SECTION 5
only)
SUPPLIERS (For private hospitals/tissue establishments and university/lab
In the space provided below or via a separate referenced document please provide information
on the suppliers of the drugs for which a licence is sought (e.g, details of a registered pharmacy
business, wholesale distributor).
SECTION 6
IMPORTING
Will you be importing controlled drugs in Ireland? (Please note that a separate import licence
may be required for each import into the country.)
Yes
SECTION 7
No
CHECKLIST OF DOCUMENTS
The following information must be submitted with the application (except where not
applicable).
Please check the boxes to confirm that documents have been included with the application.
Certificate of incorporation (if applicable). This must be provided for first time applicants
and for renewals where the company name and/or address has changed.
Declaration from An Garda Síochána, signed by a superintendent, stating that the safe
holding the controlled drugs has been inspected and has been deemed appropriate. This
certificate is valid for two years from date of issue and a copy of it must be submitted
with every application for a controlled drugs licence.
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Proof of payment made to the Department of Health (if applicable). Please note
purchase orders and cheques are not acceptable. Please contact
[email protected] for queries regarding fees.
SECTION 8
DECLARATION
I hereby declare that, to the best of my knowledge and belief, all the particulars given in this
application are correctly stated.
Signature:
____________________________________
Print name:
Date:
Title/position:
Notes:
Applications must bear the signature of the applicant. Where the application is on behalf of a
limited company the declaration must be signed by a director or the secretary and, in the
case of a partnership, by a partner.
Special attention is directed to section 21(7) of the Misuse of Drugs Act, 1977, which
makes it an offence punishable by a fine or imprisonment or both, for any person to
make a declaration or statement which is false in any particular for the purpose of
obtaining the issue, grant or renewal of a licence, authorisation or permit under the
Act.
Send to:
Controlled drugs, Licensing Section
Compliance Department
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Terrace
Dublin 2
D02 XP77
Tel:
+ 353 1 676 4971
Fax:
+ 353 1 676 7836
E-mail: [email protected]
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